Condition category
Respiratory
Date applied
04/03/2011
Date assigned
15/03/2011
Last edited
21/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Bronchiolitis is a common viral lung infection that affects babies and young children under two years old. The majority of infants admitted to hospital with bronchiolitis require supplemental oxygen, but two recent guidelines differ in what experts considered to be the correct blood oxygen level (oxygen saturation) to stop giving supplemental oxygen; one recommended 90% and the other 94%. We aimed to demonstrate that supplemental oxygen does not make any difference to symptoms if stopped at stable 90% oxygen saturation as opposed to the current 94%.

Who can participate?
Infants between 6 weeks and 12 months of age, admitted to hospital with bronchiolitis.

What does the study involve?
Participating infants were randomly allocated to either a standard or a modified monitor to measure their oxygen saturation levels during their hospital stay. Modified monitors displayed a different oxygen saturation level to that measured (within a small range). Clinical outcomes were monitored and parents were followed up to collect information on healthcare and societal costs and parental anxiety levels. Parents completed questionnaires at the start of the study and then by phone after 7 and 14 days and after 6 months to ask about their child’s health and their experience. After 28 days we again met the infants enrolled during the first year of the study to check their oxygen levels and ask about the child’s health.

What are the possible benefits and risks of participating?
Infants in the study had different types of oxygen saturation monitor but no extra tests. Our study investigated whether the use of supplemental oxygen reduces the length of illness or use of healthcare resources once an infant attains satisfactory oral feeding and a stable arterial oxygen saturation of 90% in room air (as opposed to typical 94% in room air). This difference could represent 22 hours longer in hospital.

Where is the study run from?
Five children’s hospitals in Scotland (Aberdeen, Dundee, Edinburgh, Glasgow and Kilmarnock) and three in South West England (Bristol, Exeter and Truro) took part in the study, which was coordinated by the Edinburgh Clinical Trials Unit.

When is the study starting and how long is it expected to run for?
Infants were recruited over two winters (October 2011 – March 2012 and October 2012 – March 2013) to coincide with the busy bronchiolitis season.

Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK).

Who is the main contact?
Dr Steve Cunningham

Trial website

Contact information

Type

Scientific

Primary contact

Dr Steve Cunningham

ORCID ID

http://orcid.org/0000-0001-7342-251X

Contact details

Department of Respiratory and Sleep Medicine
Royal Hospital for Sick Children
Sciennes Road
Edinburgh
EH9 1LF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 09/91/16, BIDS_1.0

Study information

Scientific title

Bronchiolitis of Infancy Discharge Study: a multi-centre, parallel-group, double blind, randomised controlled, equivalence study

Acronym

BIDS

Study hypothesis

In infants admitted to hospital with acute viral bronchiolitis, oxygen supplementation does not alter symptom duration or further healthcare use once infants have attained a stable oxygen saturation ≥ 90% in room air.

More details can be found at http://www.nets.nihr.ac.uk/projects/hta/099116
Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0006/54771/PRO-09-91-16.pdf

On 16/06/2015 the overall trial end date was changed from 29/03/2013 to 30/10/2013.

Ethics approval

South East Scotland Research Ethics Committee 03, 07/06/2011

Study design

Multi-centre parallel-group double-blind randomised controlled equivalence study

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Acute admission with bronchiolitis in infants ≥ 6 weeks and ≤ 12 months of age

Intervention

To test whether acceptance of lower oxygen saturation limits influences recovery from acute bronchiolitis, randomisation will be to a standard or modified pulse oximeter.

Standard oximeters will measure and display arterial oxygen saturation (SpO2) as usual care. Modified oximeters will measure arterial oxygen saturation as usual, but manufacturer altered internal algorithms will alter the display to nonstandard; a measured range of SpO2 85-90% will display as a range of SpO2 85-94%.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Time from randomisation to resolution of cough. For this outcome measure, we will be testing for equivalence between the two arms of the trial

Secondary outcome measures

For these outcome measures, we will be testing for difference between the two arms of the trial

1. Time from randomisation to
1.1. Fit for discharge
1.2. Actual discharge for all infants admitted with acute viral bronchiolitis (ward based data)
2. Proportion of infants with healthcare re-attendance (primary care, emergency department, readmission) (parental phone calls)
3. Change in parental anxiety score between admission and 28 days post admission (home visit questionnaire)
4. Time to return to work/usual activities for parent(s) post admission (parental phone call)
5. Time to return to nursery for infant post admission (parental phone call)
6. Family costs incurred related to time to return to work/nursery (demographic questionnaire and parental phone call)
7. Societal costs for parental return to work (demographic questionnaire and parental phone call)
8. Healthcare costs related to discharge time and subsequent healthcare utilisation (ward based data and parental phone calls)

For these outcome measures, we will be testing for equivalence between the two arms of the trial

1. Time from randomisation to re-established feeding (approximately 75% normal) (nursing observation). Accept equivalence of 20% variance, consider as 4 hours based on previous data
2. Time from randomisation to parental perspective of back to normal (feeding, sleeping and asymptomatic) (parental phone call). Accept equivalence of 2 days, based on responses of clinicians to cough resolution times
3. Awake oxygen saturation at 28 days post randomisation (home visit). Accept equivalence of 1.0% SpO2, based on studies demonstrating healthy infant oxygen saturation

Overall trial start date

03/10/2011

Overall trial end date

30/10/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Infants ≥ 6 weeks and ≤ 12 months of age, admitted to hospital with a clinical diagnosis of bronchiolitis made by a medically qualified practitioner in a emergency department (ED)/AAA

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

600

Participant exclusion criteria

1. Preterm (< 37 weeks gestation) who received home oxygen therapy in the past 4 weeks
2. Haemodynamically significant congenital heart disease
3. Cystic fibrosis or Interstitial lung disease
4. Documented immune function defect

Recruitment start date

03/10/2011

Recruitment end date

29/03/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Hospital for Sick Children
Edinburgh
EH9 1LF
United Kingdom

Trial participating centre

Royal Aberdeen Children’s Hospital
Westburn Road Fosterhill
Aberdeen
AB25 2ZG
United Kingdom

Trial participating centre

Ninewells Hospital and Medical School
Dundee
DD1 9SY
United Kingdom

Trial participating centre

Royal Hospital for Sick Children
Dalnair Street
Glasgow
G3 8SJ
United Kingdom

Trial participating centre

Crosshouse Hospital
Kilmarnock Road
Crosshouse
KA2 0BE
United Kingdom

Trial participating centre

Bristol Children's Hospital
Upper Maudlin Street
Bristol
BS2 8BJ
United Kingdom

Trial participating centre

Royal Cornwall Hospital
Treliske
Truro
TR1 3LJ
United Kingdom

Trial participating centre

The Royal Devon and Exeter Hospital
Barrack Road
Wonford
EX2 5DW
United Kingdom

Sponsor information

Organisation

The University of Edinburgh and NHS Lothian (UK)

Sponsor details

Academic and Clinical Central Office for Research and Development
Research & Development Management Suite
The Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK) (HTA 09/91/16)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Primary clinical outcome has been submitted for publication but is still under review.
2. The NIHR HTA clinical study report will be published immediately after the peer-review journal publication.
3. A further two papers are in preparation with plans to submit to peer review journals by December 2015.

Intention to publish date

01/07/2015

Participant level data

Available on request

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26364905
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26382998

Publication citations

Additional files

Editorial Notes